Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001153505
Ethics application status
Approved
Date submitted
2/10/2015
Date registered
29/10/2015
Date last updated
25/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscling-up against disability in older adults with home care packages - Implementing an evidence-based progressive resistance training service model of care.
Scientific title
Comparing the effectiveness and cost-effectiveness of progressive resistance training with no training for older adults receiving government supported home care packages.
Secondary ID [1] 287488 0
Nil
Universal Trial Number (UTN)
Trial acronym
MUAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 296230 0
Depression 296260 0
Anxiety 296261 0
Disability 296262 0
Dementia 296370 0
General health service utilisation 296371 0
Condition category
Condition code
Musculoskeletal 296530 296530 0 0
Other muscular and skeletal disorders
Mental Health 296531 296531 0 0
Depression
Mental Health 296532 296532 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive Resistance Training - two one hour group sessions per week for 24 weeks with a 24 week follow-up period.
Participants will undertake twice weekly machine-based resistance and free standing balance training for 24 weeks under the close supervision of accredited exercise physiologist experienced in delivery to older adults with complex health care needs.

Sessions will be preceded by a low intensity five minute warm-up using ergonomic walking, arm or leg cycling, or rowing machines, and followed by a five minute warm-down that includes targeted stretching. Within each session participants will undertake six resistance exercises using air-pressure driven machines proven effective in older disabled adults (HUR Australia) and balance exercises targeting static and dynamic balance, and agility.
To ensure technique development and reduce training related delayed on-set of muscle soreness (DOMS), participants will undertake a four week conditioning phase prior to training at a higher-intensity. Specifically, for the first two weeks participants will
complete 3 sets of each exercise for 8 repetitions at 50% of the predicted maximum capacity.
For the third and fourth week of training the intensity will be increased to
65% but set and repetition kept the same.

From the fifth week, the intensity will be increased to 75% of the participants predicted maximum capacity. The predicted maximum will be a conservatively assumed resistance based on the participant’s ability to complete repetitions. At the highest intensity, an accurate resistance will be reflected by the participant’s capacity to complete eight repetitions before fatigue.
Isometric extension measurements are recorded fortnightly for each of the participants to measure their performance improvement and as an indicator of global body strength and functional capacity.
Each participants provided with a swipe card that automatically uploads their individualised routine onto each of the six exercise stations. This also allows for instant tracking of attendance to the session, adherence (using all six stations), and performance (under, on or over).
Intervention code [1] 292891 0
Rehabilitation
Comparator / control treatment
Wait list control. Participants entering this group will be asked to continue with their usual care for an initial 24 week period. Within this time period there will be no restriction on receiving allied health services, attending activity groups or any other physical activities they are presently receiving or involved in. However, participants will be asked not to commit to or become involved in any new ongoing (> 1 session) activity groups that they are not referred to by their GP or specialist.
At the end of the 24 week waiting period this group will enter the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 296156 0
Physical performance
Measured by gait speed and the short physical performance battery (standing balance, a timed 2.4 metre walk and 5-time repeated chair stands)
Timepoint [1] 296156 0
Measured at baseline, 24 weeks of intervention and 24 weeks follow-up
Primary outcome [2] 296157 0
Muscle strength
Measured by hand grip strength (dynamometer) and isometric leg extension
Timepoint [2] 296157 0
Hand grip strength measured at baseline, 24 weeks of intervention and 24 week follow-up.
Isometric leg extension measured at baseline and fortnightly during the 24 week intervention and finally at 24 week follow-up.
Primary outcome [3] 296258 0
Muscle and fat mass
Measured by Bioelectric Impedance Analysis (BIA)
Timepoint [3] 296258 0
Measured at baseline, 24 weeks of intervention and 24 weeks follow-up
Secondary outcome [1] 317649 0
Economic benefit (this is a primary outcome)
Measured by modelling the:
(1) incremental cost-effectiveness of clients provided this PRT model compared to those receiving usual care. Cost will include health service utilisation costs, capital costs, overheads and transport costs. Effectiveness will be measured using the changes in primary outcomes between the two trial groups (exercise and waiting list).
(2) Cost -utility measured using the EQ-5D to derive a cost per Quality Adjusted Life Year (QALY). Costs will be those of health service utilisation costs, capital costs, overheads and transport costs. and client costs attributable to the program (e.g. self transport, memberships, opportunity costs).
(3) Cost-benefit measured from the perspective of Australian society. Costs again derived from Health service utilisation, capital costs, overheads, transport costs, client costs, opportunity costs, transfer costs. Benefits will be expressed in dollars ($AUD) over a time horizon of two years and will include reduced health care utilisation, delay entering residential aged care, improved participation/productivity and a willingness to pay determination.
Timepoint [1] 317649 0
Effectiveness and QoL data collected at baseline, 24 weeks of intervention and 24 weeks follow-up.
Cost data collected daily through diary completion, trip logs and project expenses.
Willingness to pay and qualitative information informing social benefits/costs of the program collected at dropout, 24 weeks of intervention and again at follow-up.
Secondary outcome [2] 318209 0
Sarcopenic Status: Diagnosis of sarcopenia requires the presence of both low muscle mass and low muscle function (strength or performance).
Muscle mass will be measured by BIA, muscle strength by hand grip strength, and performance by the SPPB 2.4 metre walk. The established cut-off points to define low muscle mass are less than or equal to 2 standard deviations below the norm of a young healthy population (less than 8.87 kg/m2 for men and less than 6.42 kg/m2 for women), for low muscle strength less than 30 and less than 20 kg for men and women, respectively, and low muscle performance a gait speed of less than 0.8 m/s. In addition to the physical assessment of sarcopenia, the SARC-F questionnaire will be complete as an assessment of tool validity in the target population and an Australian context and the FRAIL scale will be used to investigate relationships between sarcopenia and frailty.
Timepoint [2] 318209 0
Measured at baseline, 24 weeks of intervention and 24 weeks of follow-up.
Secondary outcome [3] 318210 0
Mental health: The Mini-Mental State Examination will be used to assess level of cognitive impairment or dementia, the Geriatric Depression Scale – Short Form will be used to evaluate level of depression and the Geriatric Anxiety Inventory used to evaluate level of anxiety .
Timepoint [3] 318210 0
Measured at baseline, 24 weeks of intervention and 24 weeks follow-up.
Secondary outcome [4] 318211 0
Nutritional status: The Mini-Nutritional Assessment Instrument Registered Trademark (MNA Registered Trademark) will be used to assess nutritional status without the need for blood analyses. The MNA Registered Trademark consists of four main components (anthropometric, and a global, dietary, and subjective assessment), and is internationally recommended as a nutrition assessment tool in nursing care
Timepoint [4] 318211 0
Measured at baseline, 24 weeks of intervention and 24 weeks follow-up.
Secondary outcome [5] 318212 0
Participation
Measured by attendance logs, motivation to attend or drop-out measured through interviews and focus groups.
Timepoint [5] 318212 0
At dropout and/or 24 weeks of trial and again at 24 weeks follow-up

Eligibility
Key inclusion criteria
Community-dwelling older adults with home support or home care packages.
- >/= 65 years
- Mobile with or without aid
- Able to follow instructions
- Able to commit to the 24 week training period
- No history of resistance training in the past 6 months
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Assistance from greater than 1 person transfer in standing
- Reablement or Restorative Commonwealth Home Support package
- Advanced falls risk
- Terminal/palliative status with less than 12 months to live
- Pacemaker
- Medication or disease with exercise contraindications
- No consent (GP or substitute-decision maker)
- Projected move into a residential aged care facility (RACF)
- Difficult to work with as a consequence of behavioural issues

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants are invited to apply and are screened for inclusion and exclusion criteria using a checklist by the project manager.
At baseline assessment eligible participants are provided with a unique identifying number by the exercise physiologist (who are assessing them) and who are blind to the allocation sequence.
The allocation sequence was computer generated by one of the investigators at a separate site prior to the assessment period.
The Project Manager then looks up the allocation sequence and matches the allocation to the unique identifying number provided to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of consecutive Study IDs is assigned to one of the two groups in 2:1 (control:intervention) ratio using computerised random allocation in blocks..
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Step wedge design to ensure that all clients receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size is based on a feasibility of delivery capacity calculation accounting for 5 participants per session training twice weekly for 24 weeks at 2 location supervised by 2 exercise physiology staff, with delivery occurring in waves. Session numbers will be increased among higher functioning participants as the project progresses and AEP gain experience with the delivery.
A power calculation was not conducted.
The primary analysis will be of individual participants’ data in the exercise versus the wait list control group, adjusted for group baseline differences. The analysis will include:
1) Repeated measures on the quantitative outcome measures between groups at the intervention two time points. A secondary within exercise group analysis will explore what if any residual impact of training was present during the follow-up period.
2) An exploratory analysis using regression analysis will look at relationship between key variable in disability and health care utilisation to identify risk factors.
3) Health economic modeling will be between the cost of intervention delivery and usual care base on Australian dollars.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/08/2015
Date of last participant enrolment
Anticipated
1/03/2016
Actual
18/03/2016
Date of last data collection
Anticipated
31/08/2017
Actual
Sample size
Target
300
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4446 0
St Vincent's Hospital Brisbane - Kangaroo Point

Funding & Sponsors
Funding source category [1] 292081 0
Government body
Name [1] 292081 0
Department of Social ServicesAged Care Service Improvement and Healthy Ageing Grants
Country [1] 292081 0
Australia
Primary sponsor type
Individual
Name
Mr. Kevin Rouse, CEO The Chermside & District Senior Citizens Centre Inc
Address
60 Kuran Street
Chermside, Queensland
Australia, 4032
Country
Australia
Secondary sponsor category [1] 290757 0
University
Name [1] 290757 0
The University of Queensland
Address [1] 290757 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 290757 0
Australia
Secondary sponsor category [2] 290758 0
University
Name [2] 290758 0
Bond University
Address [2] 290758 0
14 University Drive, ROBINA QLD
4226 AUSTRALIA
Country [2] 290758 0
Australia
Secondary sponsor category [3] 290759 0
Hospital
Name [3] 290759 0
St Vincent's Hospital
Address [3] 290759 0
411 Main Street
Kangaroo Point QLD 4169
Country [3] 290759 0
Australia
Other collaborator category [1] 278631 0
Commercial sector/Industry
Name [1] 278631 0
HUR Australia Pty Ltd
Address [1] 278631 0
PO Box 2181
Wellington Point QLD 4160

Country [1] 278631 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293563 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 293563 0
Ethics committee country [1] 293563 0
Australia
Date submitted for ethics approval [1] 293563 0
Approval date [1] 293563 0
23/07/2015
Ethics approval number [1] 293563 0
2015000879

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 565 565 0 0
/AnzctrAttachments/369338-UQ Ethics approval.pdf

Contacts
Principal investigator
Name 60410 0
Dr Tim Henwood
Address 60410 0
The University of Queensland
Brisbane, QLD 4072 Australia
Country 60410 0
Australia
Phone 60410 0
+61 424078209
Fax 60410 0
Email 60410 0
[email protected]
Contact person for public queries
Name 60411 0
Kevin Rouse
Address 60411 0
CEO
Burnie Brae
60 Kuran St
Chermside, Qld
4032
Country 60411 0
Australia
Phone 60411 0
+61 7 3624 2100
Fax 60411 0
+61 7 3624 2160
Email 60411 0
[email protected]
Contact person for scientific queries
Name 60412 0
Tim Henwood
Address 60412 0
The University of Queensland
Brisbane, QLD 4072 Australia
Country 60412 0
Australia
Phone 60412 0
+61 424078209
Fax 60412 0
Email 60412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExamining evidence based resistance plus balance training in community-dwelling older adults with complex health care needs: Trial protocol for the Muscling Up Against Disability project.2017https://dx.doi.org/10.1016/j.archger.2016.10.001
EmbaseEngineering Improved Balance Confidence in Older Adults With Complex Health Care Needs: Learning From the Muscling Up Against Disability Study.2018https://dx.doi.org/10.1016/j.apmr.2018.03.004
EmbaseSarc-F and muscle function in community dwelling adults with aged care service needs: Baseline and post-training relationship.2019https://dx.doi.org/10.7717/peerj.8140
N.B. These documents automatically identified may not have been verified by the study sponsor.